# K924930: EVITA

- Pathway: 510(k) (Traditional)
- Applicant: Drager, Inc.
- Decided: Jan 10, 1994 after 467 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
212 later devices descend from it; 1 cites it directly.
57 of 213 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K961687: EVITA 4 (1996), 211 descendants of its own
- K970460: Nellcor Puritan Bennett, 840 Ventilator System (Model 840) (1998), 174 descendants of its own
- K970165: Evita 2 Dura (1997), 140 descendants of its own
- K013642: AVEA (2002), 133 descendants of its own
- K032451: Bird Tbird Vela Ventilator (2004), 114 descendants of its own

Source page: https://510kreport.com/device/K924930
Methodology: https://510kreport.com/methodology